Product Performance Assessment Research Articles

Development And Validation of In-Vitro Release Test (IVRT) Method for Topical Complex Generic - Ganciclovir Ophthalmic Gel

Background: The in-vitro release test (IVRT) is a tool to measure the amount and the release rate of active pharmaceutical compounds released from topical semisolid dosage forms. The IVRT provides significant information for product performance assessment and evaluation. It is also used to assess the bioequivalence study (biowaivers) for topical semisolid products. Objective: The study aims to develop and validate the IVRT method for qualitative and quantitative estimation of ganciclovir topical products and to demonstrate the similarity between the marketed reference product and the in-house test product of ganciclovir ophthalmic gel. Method: The method was developed using a vertical diffusion cell with a synthetic cellulose membrane, simulated tear fluid as the receiver media, and UV detection. The IVRT study was performed at 100rpm and 32oC for 6hr. The marketed formulation containing 0.15%w/w ganciclovir was used as a reference. Result: The in-house test product of ganciclovir met all characterization criteria. The analytical method was optimized and validated with a concentration range of 2-14μg/ml and a regression coefficient of 0.9997 as per the ICH guideline. The developed IVRT method was simple, economical, linear, robust, reproducible, sensitive, specific, and selective to evaluate the drug release from the formulation. The %recovery at 6hr was found to be 84.43% and 78.68% for reference and test product of ganciclovir ophthalmic gel with correlation coefficient R2 0.9947 and 0.9921, respectively, this value justified the biowaivers between the reference and test formulation. Conclusion: This method can be utilized to check topical semisolid product quality, product performance, and product uniformity. Additionally, it can also be used to waive the requirement for bioequivalency studies for ganciclovir ophthalmic gel.

Assessment of Production Performance and Uncertainty in the UBGH2-6 Gas Hydrate Reservoir, Ulleung Basin

This study delineates the intricate dynamics of gas hydrate production in the UBGH2-6 reservoir, located in the Ulleung Basin, by deploying a comprehensive simulation model. By integrating a sensitivity analysis with Latin hypercube sampling-based Monte Carlo simulations, we evaluated the influences on gas and water production and explored the underlying uncertainties within this gas hydrate reservoir. The simulation model revealed significant findings, including the production of approximately 440 t of gas and 34,240 t of water, facilitated by a depressurization strategy at 9 MPa for a year. This highlights the pivotal roles of porosity, permeability, and thermal properties in enhancing production rates and influencing hydrate dissociation processes. Sensitivity analysis of 19 parameters provides insights into their impact on production, identifying the key drivers of increased production rates. Furthermore, uncertainty analysis examined 300 reservoir models, utilizing statistical percentiles to quantify uncertainties, projecting a median gas production of approximately 455 t. This study identifies critical factors affecting gas hydrate production and offers valuable insights for future exploration and exploitation strategies, making a significant contribution to the field of gas hydrate research.

Assessment of Productive Performance and Carcass Characteristic of Colored and White Korean Native Ducks

Assessment of Productive Performance and Carcass Characteristic of Colored and White Korean Native Ducks

Performance Assessment Berbasis Model Problem Based Learning sebagai Alternatif untuk Mengukur Keterampilan Berpikir Kritis Siswa SMP

PBL based performance assessment involves students directly and can train them to face various problems and find solutions to problems. Science learning in class VIII shows that critical thinking skills are still relatively lacking in the process of discovering concepts in the material and the ability to answer questions based on critical thinking skills. The low level of critical thinking skills is caused by students lack of conceptual discovery of the material being taught and examining the relationship between the material and solving problems in daily life, which is done directly through performance assessments, which were previously rarely implemented in the classroom. The PBL syntax embedded in the performance assessment rubric is also integrated with the critical thinking skills component. The aim of this research is to find out whether PBL-based performance assessment can be used to measure students' critical thinking abilities. This research uses a qualitative research method with a case study approach with descriptive data explanation in class VIII D of SMPN 37 Semarang. Students are asked to develop critical thinking skills through group work, with the results of practical and product performance assessment activities showing a good category. Where the practice percentage shows the lowest value with a percentage of 50% in the deduction dimension, with activities to determine conclusions and consider the results of the analysis with problems in each group to answer questions. The percentage of practice shows the highest score with a percentage of 75% in the dimensions of inference, recognition and interpretation with information analysis activities, exploration of information and conditions, identification of information obtained, presenting solutions and preventive efforts and the results of group work.

Assessment of Production Performance and Egg Quality of Commercial Laying Hens Fed Black Pepper and Red Pepper Additives

With the increasing demand for poultry products (meat and eggs) worldwide, poultry farmers want to improve the productivity of their flocks. This challenge has necessitated poultry nutritionists to offer specific nutritional strategies for improved productivity. Feed additives are recommended as one of such strategic options, and plant materials, otherwise known as phytogenics, are being extensively investigated. Therefore, the study's objective was to assess the production performance and egg quality of commercial laying hens fed black pepper and red pepper additives. A total of 210 commercial laying hens at 24 weeks of age were allotted into seven dietary treatments in a completely randomized design. Each treatment had thirty (30) birds each, replicated three times to give ten (10) birds per replicate in a study that lasted 12 weeks. The formulated diets included: a control diet with no additives; Treatments 2 and 3 had 1% and 1.5% black pepper powder; Treatments 4 and 5 had 1% and 1.5% red pepper powder; Treatment 6 had a mixture of 0.5% each of black pepper and red pepper, while treatment 7 had a mixture of 0.75% each of black pepper and red pepper. All data collected were subjected to a one-way analysis of variance using the general linear model procedure of SAS (2012). From the results obtained, the hen day production (%) was significantly highest in hens fed the diet with 1% red pepper (83.40%) and the least from hens in the control (65.56%). The control treatment also recorded the least performances in egg mass (48.76g/bird/day) and feed conversion ratios (2.58 and 2.30). Shell thickness was least (0.43mm) in hens fed the diet with 1.5% red pepper, while the thickest shell measurement of 0.50mm was recorded in Treatment 6. The highest Haugh unit of 103.77 was obtained from Treatment 4, while the least value of 96.66 was obtained from the control. Yolk colour was significantly improved in the treated groups as against what was obtained from the control group. From the results, it can be concluded that black pepper and red pepper, having improved production performance and some egg quality characteristics in the treated groups compared to the control hold great potential as dietary additives.

Comparative analysis of the growth and biochemical composition of backcrosses and their parents in abalone

Abalone is a valuable and popular seafood with high nutritional value. Interspecific hybridization and backcrossing are effective ways to improve the yield and quality of abalone. In this study, interspecific backcrosses were conducted between the hybrids of Haliotis discus hannai♀ × H. fulgens♂ and their parental species. The backcrosses comprised five populations based on crossing combinations: hybrid F1 (DF), purebreds (DD, FF) and backcross populations (DD × DF and DF × FF). The growth, survival, and muscle nutritional components of five abalone populations were compared in a 13-month culture experiment. The results showed that DF and DD × DF had significant advantages in growth and survival. For nutritional components, backcrosses had levels of crude protein, crude lipid, and glycogen that were intermediate between their parents and were biased toward the respective recurrent parents. The assessment of production performance indicated that DF and DD × DF may have potential applications in the abalone aquaculture industry. This study has provided useful information for the healthy and sustainable development of the abalone industry.

Modern approach to the comprehensive assessment of production performance of transport companies

Currently it is becoming more and more difficult to assess the efficiency of production of any transport company. This problem requires a thorough scientific analysis of functions and activities of such a complex economic facility. In this case, it is necessary to consider not only the complexity of the internal structure of the enterprise, but also the peculiarities of its interaction with the external environment. The existing methods are poorly adapted to industry specifics, are built on a limited number of parameters, and do not allow quickly and comprehensively assessing the detail of the company with the definition of problem areas. A systematic integrated assessment is needed that will allow simultaneously and effectively solving the current tasks of the enterprise, flexibly rebuilding after its production program and, at the same time, considering its long-term development. The practical significance of the study is the possibility of using the developed modern methodology for a comprehensive assessment of the production performance of a transport company for its further optimization. The obtained results will allow quantitatively and qualitatively monitoring the current state of the transport company, identifying bottlenecks, and justifying further directions of its improvement and development based on such calculated information.

PENGARUH GOOD CORPORATE GOVERNANCE DAN KEBIJAKAN MANAJEMEN CSR TERHADAP PROFITABILITAS DI INDEKS SAHAM SYARIAH INDONESIA

The purpose of this study is to analyze whether good corporate governance and corporate social responsibility can affect the level of company profitability. Which is where GCG is proxied by managerial ownership, institutional ownership, and the independence of the Board of Commissioners. CSR is proxied using the Global Reporting Initiative (GRI) G-4 indicator with 91 assessment indicators, which consist of 9 points of economic performance assessment, 34 points of environmental performance assessment, 16 points of assessment of labor practices and work comfort, 12 points of human rights assessment. people, 11 points for community assessment, and 9 points for product performance assessment. This study uses data on the financial statements of companies in the consumer goods industry listed on the Indonesia Stock Exchange Sharia Stock Index (ISSI) for the period 2017-2020. The population in this study includes all companies in the consumer goods industry listed on the Indonesia Stock Exchange as many as 41 companies. The data collection method used in this research is purposive sampling. The sample in this study were 14 companies with an observation period of 4 years so that a total of 56 companies were observed. The conclusion of this study shows that good corporate governance does not partially affect the company's profitability. Corporate social responsibility partially affects the company's profitability. And good corporate governance and corporate social responsibility simultaneously affect the company's profitability.

The effect of collaborative problem solving & collaborative project-based learning models to improve the project competences of pre-service teachers

Project competence has become a new trend in the context of current learning outcomes, as it solves most of the complex problems done by team-based projects. Project competencies are complex and very interesting objects to implement from various perspectives, one of which is through the application of the Collaborative Problem Solving (CoLPS) and Collaborative Project-Based Learning (CPBL) model. This study is focused on examining the effect of the CoLPS and CPBL models in improving student project competencies. The research method used a quasi-experimental design and was carried out on 65 student-teacher candidates in the Department of Islamic Religious Education, Raden Rahmat Islamic University Malang, 2020/2021 academic year. The research subjects were divided into two groups, the experimental group (34) and the control group (31). The experimental group was taught with the CoLPS model and the control group was taught with the CPBL model. The data used a product performance assessment instrument and were analyzed using the independent sample t-test technique. The results of the analysis show that the CoLPS model is very effective in improving student project competencies. Students taught with the CoLPS model have better product quality than students taught with the CPBL model. The results of the observations regarding the effectiveness of the two models are also discussed.

An Empirical Analog Benchmarking Workflow to Improve Hydrocarbon Recovery

Summary Benchmarking the recovery factor and production performance of a given reservoir against applicable analogs is a key step in field development optimization and a prerequisite in understanding the necessary actions required to improve hydrocarbon recovery. Existing benchmarking methods are principally structured to solve specific problems in individual situations and, consequently, are difficult to apply widely and consistently. This study presents an alternative empirical analog benchmarking workflow that is based upon systematic analysis of more than 1,600 reservoirs from around the world. This workflow is designed for effective, practical, and repeatable application of analog analysis to all reservoir types, development scenarios, and production challenges. It comprises five key steps: (1) definition of problems and objectives; (2) parameterization of the target reservoir; (3) quantification of resource potential; (4) assessment of production performance; and (5) identification of best practices and lessons learned. Problems of differing nature and for different objectives require different sets of analogs. This workflow advocates starting with a broad set of parameters to find a wide range of analogs for quantification of resource potential, followed by a narrowly defined set of parameters to find relevant analogs for assessment of production performance. During subsequent analysis of the chosen analogs, the focus is on isolating specific critical issues and identifying a smaller number of applicable analogs that more closely match the target reservoir with the aim to document both best practices and lessons learned. This workflow aims to inform decisions by identifying the best-in-class performers and examining in detail what differentiates them. It has been successfully applied to improve hydrocarbon recovery for carbonate, clastic, and basement reservoirs globally. The case studies provided herein demonstrate that this workflow has real-world utility in the identification of upside recovery potential and specific actions that can be taken to optimize production and recovery.

The implementation of peer assessment in product performance assessment in project-based learning on ecosystem materials

The teacher's difficulty in assessing student performance when students work in groups outside class hours causes the need for peer assessment to be carried out. Project-based learning is a suitable space for applying peer assessment because it consists of tasks that students in groups usually do. This study describes the application of peer assessment in product performance assessment in project-based learning on ecosystem materials. This study uses a descriptive method involving 34 high school students in class X. Peer assessment is done by students assessing the products made by their group of friends. The application of peer assessment in this study was carried out three times, namely at the stage of product design, product assessment, and product presentation. An analysis of the performance assessment results through peer assessment is conducted, and the similarity of the results of the peer assessment to the teacher's assessment at each stage. The study results showed that there was a tendency for an increasing student's ability to judge. This result is evidenced by the increasing similarity of teacher assessments and peer assessments at each stage. The similarity between peer assessment and teacher assessment at the product design stage is 58.8%; product assessment stage by 64.7%; and the product presentation stage of 70.6%. The student response questionnaire identified that the application of peer assessment provided many benefits to students. Based on the results of this study, peer assessment can be an alternative in overcoming teachers' difficulties in assessing student performance when project work is carried out outside class hours through project-based learning.

Developing an Instrument of Performance Assessment to Measure Problem-Solving Skills of Senior High School Students in Physics Inquiry-Based Learning

The assessment of students’ learning results has not been fully implemented. Whereas, the importance of assessing students is to find out the development of learning abilities in solving problems, but many obstacles are still faced by educators at SMAN (high school) 5, SMAN (high school)15, and SMAN (high school) 16 Bandar Lampung. This study aims to produce a valid product and determine the feasibility of construction, substance, and language. Sugiyono's research design development model was divided into (1) potential and problem, (2) data collection, (3) product design, (4) design validation, (5) design revision. The product is valid because the expert validator accepts the instrument in terms of both content and format, including instrument outline, learning scenario, rubric, and scoring guideline. The construction aspect score was 3.59 while the substance aspect score was 3.56, and the language aspect score was 3.58. The validation test result meets very sufficient quality criteria. Therefore, the product performance assessment instrument to measure problem-solving skills in physics inquiry-based learning of senior high school students can be used.

New Product Pricing Strategy and Product Performance Assessment in Fast Moving Consumer Goods

Purpose: This article combines the two perspectives of management interests, namely marketing and finance regarding Fast Moving Consumer Goods (FMCG). The aim is to uncover the marketing environment on pricing strategies in a competitive market environment, product and financial performance as well as assessing product success based on price strategies. Design/methodology/approach: Qualitative research methods are used by the design of a combination of grounded theory and phenomenology, as well as constructive approaches. Findings: The results identify that the marketing environment in terms of price is a consideration of buyer’ decisions and is related to the product marketing environment, and the environment of market competition, namely price activities, antecedents and price outcomes. The marketing environment of price is created based on the marketing environment of product and consumer market competition, while the product performance is determined by the environment of business and consumer market competition. These findings contribute to the conception of business buyer behavior and the marketing mix. Practical implications: The results implications refer to the practice of corporate management on financial management of working capital, and marketing management in general. Originality/value: The originality of this paper comes from the exploration of pricing strategies in an effort to determine the relevance between product performance and finance, and the success of new "FMCG" products.

Practicality of Performance Assessment Instruments in Measurement Topic 10th Grade Secondary School

One of the competencies in Curriculum 2013 is having the skills to apply knowledge in doing scientific inquiry, while the skills are divided into two kinds: concrete and Achievement of these competencies can be determined by assessment. The information of student’s ability given by authentic assessment is believed to be more holistic and valid, one of them is performance assessment. It is conducted to assess how appropriate the students in completing their tasks in the form of action or deed. The aim of this research is to obtain a description of the practicality and percentage of agreement of performance assessment instruments on measurement topic for 10th grade secondary school. This research subject of trial as many as 19 students in 10th science class at SMA Muhammadiyah 2 Surabaya with trial design one group pre-test post-test. Data are collected by using observation and direct questionnaire methods. The results showed that the practicality of the instrument based on the implementation of the assessment and the results of student responses fulfills the practical criteria and agreement between observers on the implementation of product performance assessment and process performance assessment are well categorised.

Performance indicator for potential health impact analysis within LCA framework and for environmental product declaration (EPD)

This article proposes an approach describing relative potential toxicological performances of products and allows for comparisons with other products with identical functions. The scores derived at the substance level may be aggregated to the product level for each of the life cycle stages of the product. This approach is intended to become a tool for performance assessment of products. It provides complementary information in addition to results from LCA for environmental product declarations (EPD). This article focuses on describing the impact on human health from exposure to construction products and to their ingredients, compatible with “life cycle thinking”. Ingredient substances can be part of the intended composition or can be relevant residues like monomers in plastics or defined contaminants. The proposed approach can also describe the toxicological impact for other than construction products. The method describes a dimensionless score suitable for ranking with three characteristics: (1) By a hazard score, it describes chemical products for different applications, e.g. for construction, with regard to the inherent toxicity for humans of their ingredients. (2) It considers exposure potentials to the product’s ingredients by a generic adjustment factor, which may modify potential health impacts. (3) It addresses not only the use stage of a product and its ingredients (e.g. as construction material in a building), but it also includes other life cycle stages of the product’s ingredients. The specific method is described which is still under testing. Therefore, no results of any application can be published so far. Since the method provides a scalable, dimensionless score of potential toxicological impacts, independent of time and location, these scores can in principle be aggregated to the building level, comparable to the life cycle assessment (LCA)-based information in an EPD. The different factors make use of the extensive toxicological and exposure data generated under REACH regulation but are not limited to these. Interpretation of such data differs from REACH. The method can be further developed into a tool for product and building assessment and be provided as (voluntary) additional information in an EPD. It is recommended that the basic concept be adapted to the needs of the users of the information generated with this method (e.g. architects, building assessment) and the providers of information (manufacturers). An intense consultation process with other stakeholders should be organised to establish a final method into a guidance document for unambiguous application.

Normalisation in life-cycle assessment: consequences of new European factors on decision-making

ABSTRACTEnvironmental performance assessment of products is necessary to improve sustainability in supply chains. Life-cycle assessment and its optional normalisation step may be used for this purpose. Based on an illustration, this paper studies the most recent International reference Life-Cycle Data system (ILCD) normalisation factors and compares them with the most commonly used normalisation factors given by CML and ReCiPe H methods. Normalisation with ILCD shows differences in the results, compared to normalisation with older methods, which may have consequences on business decisions. Indeed, some impact categories are undervalued with old methods because their factors are not up to date. We conclude on the importance of using the latest methods to assess environmental impacts, and on the need to link these approaches or metrics with supply-chain performance evaluation models.

Results from a First-in-Human Trial of a Novel Vascular Sealant

Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX ((®)) ) is a polyaldehyde-bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study. A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance. Fifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10 min of observation. The three most common adverse events were graft or bypass occlusion (n = 5 patients), infection (n = 4), and seroma (n = 3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts. PreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial.

Technology Focus: Reservoir Performance and Monitoring (September 2013)

Technology Focus “All models are wrong, but some are useful.” This famous quote by George E.P. Box illustrates both the challenge and the appreciation of building models. Models are needed to predict future performance of an oil or gas field, but, at the same time, models are often biased and inaccurate. Most investment decisions rely on our ability to predict and to plan the future, and, in that regard, nothing is more important than accurately modeling future well performance. Consequently, three of the four chosen papers address different aspects of this topic. The first paper deals with ways to improve the accuracy of our predictions. It offers readers a rigorous checklist of questions to ask when developing reservoir models to guide them toward less-biased forecasts. The second paper deals with how we develop reservoir-prediction tools for asset management. Active reservoir management addresses the almost impossible task of maximizing short-term production while optimizing ultimate recovery. However, to evaluate the different reservoir-drainage mechanisms, one needs good models, and the more advanced the drainage mechanism is, the more crucial the model is. As an illustration, it is much easier to model a pressure-depletion scheme than to try to predict a secondary- or tertiary-recovery process. Assessing and quantifying uncertainties as part of the modeling are becoming increasingly common, and this practice improves the ability to develop a sound decision basis. The development of unconventional shale resources has further challenged the ability to predict performance. Prediction of such unconventional resources does not necessarily require new tools but rather new assumptions and new experience-based calibration methods. More than 40% of the papers I reviewed for this issue dealt with prediction of production and ultimate recovery of shale gas, which clearly illustrates the increasing interest in this topic and the current challenges faced by today’s petroleum engineers. The lack of history and of good analogs further adds to the uncertainty. I am sure that more research and the availability of more production data will enable us to develop better models and, hence, increase the accuracy of our predictions. The third paper provides great insight into our understanding of unconventionals. Recommended additional reading at OnePetro: www.onepetro.org. OTC 23949 In-Well Distributed Fiber-Optic Solutions for Reservoir Surveillance by Juun van der Horst, Shell, et al. IPTC 16866 Uncertainty Assessment of Production Performance for Shale-Gas Reservoirs by Jiang Xie, Chevron, et al. IPTC 16505 Joint Inversion of Time-Lapse Crosswell Seismic and Production Data for Reservoir Monitoring and Characterization by Lin Liang, Schlumberger, et al.

Assessment of production performance in 2 breeds of broilers fed prebiotics as feed additives

Pasture-flock-raised poultry are becoming an increasingly popular product, but only limited options are currently available for maintaining gut health. For these producers, prebiotics are an attractive option because they are generally recognized as safe (GRAS) and can be mixed into the feed and thus do not require adjustments to production protocols. However, if prebiotic treatments reduce production performance, they would not be useful to producers. Thus, the objective of this study was to measure performance of pasture-raised broilers fed 1 of 3 prebiotic treatments. For these trials, 2 breeds of birds were used: Naked Neck slow-growing breeds and Cornish White Rock cross fast-growing breeds. The experimental design was replicated for each breed. A total of 340 birds were split into 4 groups, each group fed one feed additive: 1) galactoligosaccharides (2% wt/wt), 2) fructooligosaccharides (1% wt/wt), 3) plum fibers (1% wt/wt), or 4) no additives. During the 8-wk rearing period, 10 birds from each group were collected and euthanized to take small intestine samples. Histological preparations were made from the small intestine tissue, and 4 measurements of villi height and crypt depth from each cross section were taken. Throughout the study, mortality was monitored and BW measurements were taken at 2-wk intervals. For the Cornish White Rock cross, the group receiving the feed supplemented with fructooligosaccharides had higher (P < 0.05) 8-wk BW than those fed Plum; control and birds fed galactoligosaccharides were intermediate. For the Naked Neck breed, the group receiving the plum fibers had the highest final BW. It appears that all 3 feed supplements offered some protective effect for alterations in villi length and crypt depth due to feed withdrawal, but only for the Naked Neck breed. The data indicate the 3 prebiotics utilized in this study could be used without risk of decreasing production performance, but only for Naked Neck breeds.

The WellPoint Outcomes Based FormularySM: enhancing the health technology assessment process

SummaryThe purpose of this paper is to present an overview of the evidentiary and analytical standards recommended by WellPoint Pharmacy Management (WPM) in the formulary submission and re-evaluation process for drug products. Given our commitment to The WellPoint Outcomes Based FormularySM, the guidelines emphasise the importance of randomised, active comparator, naturalistic trials in supporting the clinical and cost-effectiveness case for a drug product. In addition, the guidelines emphasise the need to monitor and validate claims made for the product over its life cycle. Whilst modelled cost-effectiveness claims have a place in formulary assessment, any claim must be amenable to empirical evaluation. It is these requirements for naturalistic trials and the assessment ofproduct performance at the health system level that set the WPM guidelines apart. Further, in stating a preference for product performance claims to be expressed in generic cost per quality-adjusted life-year (QALY) terms, WPM is setting a standard for the development of an objective measure to support resource allocation decisions.In the first part of the paper, WPM's commitment to the principles of The WellPoint Outcomes Based Formulary is reviewed, together with the role of monitoring and validation in the assessment of clinical and modelled cost-effectiveness and system impact claims in formulary evaluation. The second part of the paper details the guidelines' recommendations for new product assessments in terms of: (i) product descriptionand indication; (ii) target population, treatment patterns and place in therapy; (iii) clinical assessment; (iv) cost-outcome assessment and product claims; (v) budget and system impact claims; and (vi) validating and monitoring claims. The third part of the paper details the guidelines' recommendations for product re-evaluation. These recommendations are assessed in terms of: (i) monitoring and validating initial claims for product performance; and (ii) re-evaluating claims for cost-effectiveness and system impact given changes in the competitive landscape for products and procedures in the disease state and the increased awareness of comparative clinical performance of competing products and procedures.